Durvalumab - PharmaKB

Imfinzi(durvalumab)

Imfinzi (durvalumab) is an antibody pharmaceutical. Durvalumab was first approved as Imfinzi on 2017-05-01. It is used to treat transitional cell carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against programmed cell death 1 ligand 1.

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Drug

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Variants

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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
respiratory tract diseases	D012140

Trade Name

FDA

EMA

Imfinzi

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Durvalumab

Tradename	Proper name	Company	Number	Date	Products
Imfinzi	durvalumab	AstraZeneca UK Ltd	N-761069 RX	2017-05-01	2 products

Labels

FDA

EMA

Brand Name	Status	Last Update
imfinzi	Biologic Licensing Application	2023-06-16

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
transitional cell carcinoma	—	D002295	—

Agency Specific

FDA

EMA

Expiration	Code
durvalumab, Imfinzi, AstraZeneca UK Ltd
2029-10-21	Orphan excl.

Patent Expiration

No data

ATC Codes

L: Antineoplastic and immunomodulating agents

— L01: Antineoplastic agents

— L01F: Monoclonal antibodies and antibody drug conjugates

— L01FF: Pd-1/pdl-1 (programmed cell death protein 1/death ligand 1) inhibitors

— L01FF03: Durvalumab

HCPCS

Code	Description
J9173	Injection, durvalumab, 10 mg

Clinical

Clinical Trials

742 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-small-cell lung carcinoma	D002289	—	—	37	95	31	2	15	167
Neoplasms	D009369	—	C80	40	29	—	1	2	58
Lung neoplasms	D008175	HP_0100526	C34.90	13	35	3	1	5	49
Neoplasm metastasis	D009362	EFO_0009708	—	1	—	—	1	—	2

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	23	30	1	—	1	44
Hepatocellular carcinoma	D006528	—	C22.0	11	26	6	—	4	41
Liver neoplasms	D008113	EFO_1001513	C22.0	9	22	5	—	4	35
Squamous cell carcinoma of head and neck	D000077195	—	—	17	21	3	—	1	35
Small cell lung carcinoma	D055752	—	—	6	16	4	—	3	29
Ovarian neoplasms	D010051	EFO_0003893	C56	15	18	1	—	—	26
Urinary bladder neoplasms	D001749	—	C67	10	19	2	—	—	26
Renal cell carcinoma	D002292	EFO_0000376	—	8	14	2	—	1	21
Sarcoma	D012509	—	—	7	10	1	—	—	14
Biliary tract neoplasms	D001661	—	C24.9	3	12	1	—	—	14

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Colorectal neoplasms	D015179	—	—	17	26	—	—	—	34
Pancreatic neoplasms	D010190	EFO_0003860	C25	17	23	—	—	—	32
Triple negative breast neoplasms	D064726	—	—	10	13	—	—	—	20
Melanoma	D008545	—	—	11	9	—	—	2	18
Head and neck neoplasms	D006258	—	—	11	12	—	—	1	16
Stomach neoplasms	D013274	EFO_0003897	C16	7	12	—	—	—	14
Cholangiocarcinoma	D018281	—	C22.1	3	12	—	—	—	14
Prostatic neoplasms	D011471	—	C61	4	9	—	—	—	11
Uterine cervical neoplasms	D002583	HP_0030159	—	7	7	—	—	—	11
Esophageal neoplasms	D004938	—	C15	4	9	—	—	—	10

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Primary myelofibrosis	D055728	—	D47.4	2	—	—	—	—	2
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	1	—	—	—	—	1
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340	—	1	—	—	—	—	1
Myelomonocytic leukemia chronic	D015477	—	C93.1	1	—	—	—	—	1
Anemia	D000740	HP_0001903	D64.9	1	—	—	—	—	1
Hodgkin disease	D006689	—	C81	1	—	—	—	—	1
Leukemia myeloid chronic atypical bcr-abl negative	D054438	—	C92.2	1	—	—	—	—	1
Myeloid leukemia chronic-phase	D015466	—	—	1	—	—	—	—	1
Thrombocytosis	D013922	HP_0001894	D75.83	1	—	—	—	—	1
Polycythemia	D011086	EFO_0005804	D75.1	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Heart diseases	D006331	EFO_0003777	I51.9	—	—	—	—	2	2
Myocarditis	D009205	—	I51.4	—	—	—	—	2	2
Autoimmune diseases	D001327	HP_0002960	M30-M36	—	—	—	—	2	2
Cardiovascular diseases	D002318	HP_0001626	—	—	—	—	—	1	1
Cardiomyopathies	D009202	EFO_0000318	I42	—	—	—	—	1	1
Pericarditis	D010493	EFO_0007427	I30	—	—	—	—	1	1
Vasculitis	D014657	HP_0002633	—	—	—	—	—	1	1
Myositis	D009220	EFO_0000783	G72.49	—	—	—	—	1	1
Arthritis	D001168	HP_0001369	M05-M14	—	—	—	—	1	1
Endocrine system diseases	D004700	EFO_0001379	E34.9	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Durvalumab
INN	durvalumab
Description	Durvalumab (human mab)
Classification	Antibody
Drug class	monoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	>5X8M:B\|durvalumab heavy chain EVQLVESGGGLVQPGGSLRLSCAASGFTFSRYWMSWVRQAPGKGLEWVANIKQDGSEKYYVDSVKGRFTISRDNAKNSLY LQMNSLRAEDTAVYYCAREGGWFGELAFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTHHHHHH >5X8M:C\|durvalumab light chain EIVLTQSPGTLSLSPGERATLSCRASQRVSSSYLAWYQQKPGQAPRLLIYDASSRATGIPDRFSGSGSGTDFTLTISRLE PEDFAVYYCQQYGSLPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS QESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC